Protocol Translation and CRF Design

Principles of CRF Design

Table 1

30-45 minutes Foundational Step 6 of 7

Table

Table 1

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Table

Table 1

Principle	Meaning	Practical implication
Clarity	Questions should be interpreted consistently	Use precise field labels and completion guidance
Necessity	Fields should serve a defined purpose	Remove variables not linked to objectives, safety, compliance, or analysis
Logical flow	Forms should follow workflow	Order questions according to visit or clinical sequence
Consistency	Similar data should be collected similarly	Standardize coding, date formats, units, and terminology
Analysis readiness	Data should support planned analysis	Prefer coded fields over free text for analyzable variables
User-centered design	Forms should be practical to complete	Minimize burden and use branching logic where appropriate